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ADVAITE RESPONDS TO CHESTER COUNTY SUIT, REAFFIRMS COMMITMENT TO FIGHTING SPREAD OF COVID-19
The Chief Executive Officer of Malvern-based biotech company Advaite Inc. has responded to reports of a lawsuit brought by Chester County over a contract for the purchase of a million COVID-19 rapid test kits developed and manufactured by Advaite.
Since the earliest days of the COVID pandemic last year, Advaite’s leadership team and professional staff have worked tirelessly and with a singular focus on the development of effective diagnostic tools to combat and contain the onslaught of the deadly virus in Pennsylvania and beyond.
Those efforts came to fruition with the development of the RapCov™ Rapid COVID-19 Test, a groundbreaking new serology test designed to accurately identify the presence of COVID-19 antibodies in the bloodstream, and delivering results of testing of the point of care. Such is the value of this tool that ADVAITE is one of only a handful of biotech companies to have received Emergency Use Authorization (EUA) from the United States Food and Drug Administration for the distribution and implementation of the RapCov™ Rapid COVID-19 Test.
In the spring of 2020, Advaite entered into a contract with Chester County for the county’s purchase of one million RapCov™ Rapid COVID-19 kits to conduct wide-scale testing among county residents. The tests were authorized for distribution under FDA’s Section IV.D Notification Policy of the March 2020 guidance..
“Advaite was proud about entering into a contractual relationship with Chester County,” said Karthik Musunuri, Advaite’s CEO. “Given that Advaite is headquartered in Malvern [a township in Chester County], it’s particularly meaningful and gratifying to play an important role in taking on the pandemic right here in our own backyard.”
Notwithstanding Advaite’s efforts over the course of spring and summer to get its test kits into the hands of Chester County public health authorities. Advaite aggressively invested in manufacturing capabilities, materials and methods to manage the county’s needs. At a great cost Advaite set-out to both invest and manufacture kits to enable the county to oversee distribution and administration to residents, the county’s evident communication challenges, disorganized handling, and poor training methods of the product resulted in scores of FDA-authorized test kits languishing unused in warehouses. At the same time, poorly coordinated public communication efforts on the part of the county served only to sow confusion, further undermining Advaite’s objective of seeing the tests successfully administered to patients. Advaite passed on numerous other customer orders to manufacture product in good faith to Chester County.
“It’s quite evident by now that this lawsuit is a thinly veiled attempt on the part of Chester County to divert attention from its own internecine squabbling, incompetence, a lack of sense of urgency and total failure around the distribution of Advaite’s test kits,” said Ajay Raju, attorney for Advaite. “But the real tragedy is that the county leadership’s failure to do the right thing, and to do it correctly, cost lives and is jeopardizing the health of their own constituents, and making it more difficult for actors like Advaite to effectively wage battle against this deepening epidemic.”
Raju emphasized that Advaite intends to “vigorously defend” itself against Chester County’s claims, and is currently considering bringing several counterclaims against the County. Meanwhile, Advaite’s CEO has struck an optimistic tone. “Advaite’s paramount objective has always been to develop, distribute and administer an effective test to help individuals and communities win the fight against the COVID-19 pandemic,” said Musunuri. We remain hopeful that Chester County will set aside these meritless claims, and join us again in that fight to finally bring this crisis to an end.”
- Advaite Inc. is a Malvern, PA headquartered biotechnology company focused on developing novel diagnostics and therapeutics to help patients’ suffering from debilitating diseases. The team at Advaite consists of industry veterans from Pfizer, GSK and Merck along with scientists with respected backgrounds across immunology, virology and molecular biology encompassing top academia institutions and dozens of publications. Advaite currently has a state-of-the art R&D facility located in Malvern, PA; supporting the full scale development of diagnostics and small molecule therapeutics from feasibility until commercialization and scale-up manufacturing. Advaite also has a presence in Chicago, IL at the UIC Laboratory Incubator Facility operating as a high complexity CLIA laboratory (CLIA #14D2191276), aiding in the high throughput testing of COVID-19 and other diseases using FDA authorized devices.
- The RapCov™ Rapid COVID-19 Test is a lateral flow immunochromatographic assay for the presumptive qualitative detection of IgG antibodies to the COVID19 virus in human whole blood fingerstick samples. When present in the patient sample, COVID-19 specific IgG antibodies bind to anti-human antibodies (IgG) immobilized in a line across the RapCov™ cassette membrane. Colloidal gold complexes containing recombinant COVID-19 nucleocapsid antigens are captured by the patient’s IgG antibodies to give a visible pink line. A procedural control is included to indicate that the assay has been performed correctly and is valid. It is presently not known how long antibodies to SARS-CoV-2 last, as levels may start to decline in some individuals within 2-3 months post infection.
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Nearly all immunocompetent individuals will develop an immune response following SARS-CoV-2 infection. Like infections with other pathogens, SARS-CoV2 infection in humans elicits development of various types of antibodies including IgM and IgG antibodies, which are the most useful for assessing antibody response. It is still not currently known how long antibodies to SARS-CoV-2 last, as in some individuals they can start declining within 2-3 months post infection.
Antibodies in some infected persons can be detected within the first week of illness onset. In SARS-CoV-2 infections, IgM and IgG antibodies can arise nearly simultaneously in serum within 2 to 3 weeks after illness onset. Thus, detection of IgM without IgG is uncommon. How long IgM and IgG antibodies remain detectable following infection is not entirely known. It is also important to note that some infected persons do not develop detectable IgG or IgM antibodies following infection. Thus, the absence of detectable IgM or IgG antibodies does not necessarily rule out that they could have previously been infected.
A recent study on 30,576 persons evaluating the humoral immune response in Iceland indicated that antiviral antibodies against SARS-CoV-2 did not decline within 4 months after diagnosis. 1 Specifically, IgG antibody levels increased during the first 6 weeks after diagnosis; while IgM antibody levels increased rapidly soon after diagnosis and then fell rapidly and were not detected after 2 months.
Detection of SARS-CoV-2 Infection Relative to Symptom Onset ² (Green Line = IgG)
High titers of IgG antibodies have been shown to positively correlate with neutralizing antibodies.³¹ Alter Galit, Seder Robert. (2020) The Power of Antibody-Based Surveillance. N Engl J Med DOI: 10.1056/NEJMe2028079.
² JAMA. 2020;323(22):2249-2251. doi:10.1001/jama.2020.8259
³ To KK-W, Tsang OT-Y, Leung W-S, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020;20(5):565-574. doi:10.1016/S1473-3099(20)30196-1 - See more benefits and references here: https://rapcov.com/covid-19-virus-disease/
US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for emergency use of RapCov Rapid COVID-19 Test (EUA # 202686, issued on 1/11/2021).
RapCov Rapid COVID-19 Test is a lateral flow immunoassay intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick whole blood specimens. The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Testing of fingerstick whole blood specimens is limited to laboratories certified under CLIA, that meet the requirements to perform high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens is authorized for use at the POC, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- This test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for detecting the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
ADVAITE’s RapCov™ COVID-19 Rapid Test (IgG) has received CE Mark Clearance and is available for purchase and distribution within the EU.
ADVAITE’s authorized representative for the EU is:
OBELIS S.A.
Bd Général Wahis, 53
B-1030 Brussels
Belgium
Tel: +3227325954
Fax: +3227326003
mail@obelis.net
Advaite completed independent, third-party run, protocol driven studies in the United States on US subjects in order to assess sensitivity, specificity, overall accuracy and cross-reactivity. See: https://rapcov.com/clinical-studies/ for more information.
- The start to finish manufacturing and final release of the RapCov™ COVID-19 Rapid Test is all done in Pennsylvania, USA at local sites in the Philadelphia region. Advaite uses a reputable, well established CMO named Frontida Biopharm Inc. (based in Philadelphia, PA) to manufacture, package and release final product from their GMP facility. Advaite manufactures all bulk substance in-house including recombinant protein out of Malvern, PA. A majority of the RapCov™ test kits components are US based, including the MicroSafe pipettes, lancets and other raw materials that make up the composition of each test. The personnel involved in the commercial production of the RapCov™ test kits include many bioengineers, molecular biologists, and biochemists with advanced training and years of skillset working in assay development.
